DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hcl oral solution 
MAJOR® PHARMACEUTICALS

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Diphenhydramine HCl Oral Solution 12.5 mg/5 mL

Diphenhydramine HCl Oral Solution 25 mg/10 mL

Drug Facts

Active ingredient per 5 mL (1 Unit Dose)

Diphenhydramine HCl 12.5 mg

Active ingredient per 10 mL (1 Unit Dose)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies:

   • runny nose                   • sneezing  

   • itchy, watery eyes         • itching of the nose or throat

Warnings

Do not use

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

• a breathing problem such as chronic bronchitis
• glaucoma

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions 

For the 5 mL Unit-Dose: 

• take every 4 to 6 hours, or as directed by a physician

• do not take more than 6 doses in 24 hours

agedose
Children under 2 years of ageDo not use
Children 2 to under 6 years of ageDo not use unless directed by a doctor
Children 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg)

Directions

For the 10 mL Unit-Dose:

• take every 4 to 6 hours, or as directed by a physician
• do not take more than 6 doses in 24 hours

agedose
Children under 6 years of age                   Do not use
Children 6 to under 12 years of age               10 mL (25 mg)
Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg) 

Other information

• each 5 mL contains sodium: 3 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken

Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments? (855) 879-4368

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

(800) 616-2471

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7323-41

Each 5 mL Contains:

Diphenhydramine HCL Oral Solution 

12.5 mg/5 mL

Antihistamine

Delivers 5 mL • See insert

For Institutional Use Only

Cherry Flavor 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Sugar Free • Alcohol Free

5mLPrincipalDisplay

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7324-66

Each 10 mL Contains:

Diphenhydramine HCL Oral Solution 

25 mg/10 mL

Antihistamine

Delivers 10 mL • See insert

For Institutional Use Only

Cherry Flavor 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Sugar Free • Alcohol Free

10mLPrincipalDisplay

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hcl oral solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7323-70100 in 1 BOX, UNIT-DOSE01/22/2024
1NDC:0904-7323-415 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/22/2024
DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hcl oral solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7324
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7324-72100 in 1 BOX, UNIT-DOSE01/22/2024
1NDC:0904-7324-6610 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/22/2024
Labeler - MAJOR® PHARMACEUTICALS (191427277)

Revised: 3/2024
Document Id: 14067af4-f6f6-b19a-e063-6394a90ab3cf
Set id: 0f9015c9-a95a-5703-e063-6394a90a6ad2
Version: 2
Effective Time: 20240319
 
MAJOR® PHARMACEUTICALS